What you need to know about Pfizer’s FDA Approval
On August 23rd, the Food and Drug Administration approved the first COVID-19 vaccine, the Pfizer-BioNTech COVID-19 vaccine. On the market, it will be known as Comirnaty, for the prevention of COVID-19 in individuals aged 16 years or older.
This approval does not apply for the use on ages 12–15, a third dose for immunocompromised people or booster shots, but these stipulations are still under Emergency Use Authorization. Moderna or Johnson & Johnson are not yet FDA approved.
In data collected by the Kaiser Family Foundation, 31 percent of people who are unvaccinated stated they would get the vaccine if it moved from EUA to full FDA approval; 49 percent stated they would still “wait and see” after FDA approval.
Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee, said full approval is “more psychological than anything else[…]you already have more than 320 million doses administered that are out there. The vaccines already have an enormous safety and efficacy profile.”
With the FDA’s approval, unvaccinated Americans may be more inclined to to receive this vaccine, private businesses may now have more confidence in implementing vaccine mandates as well. Large companies like Walt Disney and Walmart have already begun having vaccine mandates, but now with full approval, smaller companies and those who were hesitant to set a vaccine mandate will be less apprehensive. This has come after months of pressure from the scientific community, and other groups advocating for the vaccine, to approve the Pfizer vaccine since their application for approval in May.
FDA approval now means that Pfizer-BioNTech can now begin to advertise their vaccine directly to U.S consumers as well, this is impossible under an EUA. This will allow the vaccine to remain on the market even when the U.S is no longer considered in a state of emergency due to the pandemic.
Current FDA Commissioner, Janet Woodcock, said in a statement that the Pfizer vaccine met the FDA’s “high standards for safety, effectiveness, and manufacturing quality,” during the FDA’s media briefing. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.” She continued.
The FDA sorted through “hundreds of thousands of pages” of vaccine data from the 40,000 participants involved in the trials, assessing its 91 percent effectiveness rate of COVID-19 prevention in the real-world — which is only slightly lower than the 95 percent efficacy rate shown in the trial data during the emergency use authorization period. The FDA conducted their own analyses of the safety of the vaccine and its manufacturing facilities.
The FDA and the Centers for Disease Control and Prevention also have monitoring systems in place to ensure that any safety concerns that could arise are identified and evaluated in a timely manner. The FDA is also requiring the company to conduct post marketing studies on the risks of myocarditis and pericarditis found in some individuals after receiving the vaccine; these are to be long-term studies. The company has also agreed to conduct a pregnancy registry to study pregnancy and infant outcomes after receival of the vaccine during pregnancy.
Please note that the FDA approval is different from the emergency use approval. An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
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References:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
